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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name nitrophenylphosphate, alkaline phosphatase or isoenzymes
510(k) Number K002285
Device Name ATAC PAK ALP REAGENT KIT
Applicant
ELAN DIAGNOSTICS
231 NORTH PUENTE ST.
BREA,  CA  92821
Applicant Contact WYNN STOCKING
Correspondent
ELAN DIAGNOSTICS
231 NORTH PUENTE ST.
BREA,  CA  92821
Correspondent Contact WYNN STOCKING
Regulation Number862.1050
Classification Product Code
CJE  
Date Received07/26/2000
Decision Date 09/26/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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